The same Gleevec therapy that you and your patients have come to know

• Assurance with 400mg tablets that patients get the dose they need with the added convenience of taking just 1 tablet a day
  
• Therapy with smaller 100mg tablets for patients prescribed 600mg daily

The change in dosage form to Gleevec tablets may raise concern among patients. Those already receiving Gleevec therapy may need reassurance during the transition, while new Gleevec patients may need their own questions answered. Listed below are key issues that should be addressed with all patients regarding the new Gleevec tablets. This information should help patients to better understand and feel comfortable with the new dosage form.

If patients have additional questions or concerns, they can call the Gleevec Hotline at 1-877-GLEEVEC (1-877-453-3832).

Gleevec was changed from capsules to tablets to offer greater convenience to all patients

Novartis has developed the new Gleevec tablets to make therapy more convenient for all patients. Taking the prescribed dose of Gleevec is important in acheiving the best results. Many patients taking Gleevec are prescribed a daily dose of 400mg. New 400mg tablets help to ensure that these patients get their prescribed dose more conveniently. Patients now take just 1 tablet a day instead of 4 capsules a day. The 400mg tablets are also more convenient for patients prescribed 800 daily, who now take just 1 tablet twice a day instead of 4 capsules twice a day.

The new 100mg tablets have been scored to accommodate dosing for pediatric patients (recently approved indication for Gleevec). The recommended dosage of Gleevec is based on body size (260mg/m2/day) for children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase whose disease has returned after stem cell transplant (SCT) or who are resistant to interferon-alpha (IFN-α) therapy. For adult patients required to take multiple tablets a day, such as those initially prescribed or escalated to 600mg daily, the 100mg tablet is smaller than the 100mg capsule.

It is important to explain to patients the rationale for the new dosage form because they may initially be reluctant to make the change. Without understanding why their therapy has changed, patients may make their own assumptions and become unnecessarily concerned. Once they understand that the tablets were developed to make therapy more convenient for all patients, they should be more comfortable with the transition.

You will receive exactly the same medicine in the new Gleevec tablets

Some patients may wonder if the tablets are the same as the capsules. It is natural to have this concern. Importantly, patients must be assured that they will receive exactly the same medicine in the new Gleevec tablets that they have come to know. The only difference with the tablets will be the added convenience during therapy.

This is perhaps the greatest concern patients will have regarding the transition to Gleevec tablets. They must be made to understand that although the tablets look different, they contain the same active ingredient as Gleevec capsules. Without their firm belief in the equivalence of the dosage form, patients may be reluctant to make the transition.

Take each dose of Gleevec as directed

During the transition to tablets, it is critical for patients to understand any changes in their treatment, such as the number of tablets they must take each day. They must also understand the importance of compliance in achieving optimal results.

Patients should take Gleevec tablets with a meal and a large glass of water, just as capsules were taken.* They should be strongly discouraged from stopping Gleevec or changing the dose on their own. In addition, patients should avoid taking any other medications, including over-the-counter medications such as acetaminophen (for example, Tylenol®†) or herbal products, without talking to you or their pharmacist first.

Patients taking 400mg daily need to adjust to taking only one 400mg tablet a day instead of four 100mg capsules a day. Patients taking 600mg daily must understand that they now take six 100mg tablets a day instead of six 100mg capsules a day. Patients taking 800mg daily need to adjust to taking only one 400mg tablet twice a day instead of four 100mg capsules twice a day. †Tylenol (acetaminophen) is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

As patients transition to Gleevec tablets, they must be aware of the appropriate number of tablets to take each day; otherwise, overdosing or underdosing is a possibility, each with potentially serious implications. Brochures have been enclosed to help patients acclimate to therapy with new Gleevec tablets.

Important safety information

The majority of patients who received Gleevec® in clinical studies experienced adverse events, but they were usually mild or moderate. Of the approximately 1700 patients in these studies, the most common adverse events (all grades) were superficial edema (53%–76%)*, diarrhea (30%–60%), nausea (43%–71%), vomiting (15%–56%), fatigue (29%–41%), muscle cramps (27%–55%), musculoskeletal pain (11%–46%), abdominal pain (23%–37%), and rash (26%–44%).† In most cases, these events were managed without having to reduce the dose of Gleevec or interrupt treatment. In CML, Gleevec was discontinued because of adverse events in only 2% of patients in chronic phase, 3% in accelerated phase, and 5% in blast crisis. In gastrointestinal stromal tumors (GIST), only 8% of patients discontinued treatment because of adverse events.

Severe (NCI Grades 3/4) lab abnormalities—including anemia, neutropenia, thrombocytopenia, and hepatotoxicity—and severe musculoskeletal pain and fluid retention (including severe superficial edema)*, and severe hemorrhage were reported among some Gleevec recipients.

Use of Gleevec is contraindicated in patients with hypersensitivity to imatinib or to any other component of Gleevec.

Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec.

Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6, and CYP2C9.

Please see full Prescribing Information for potential drug interactions.

Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening.

†Percentages reflect the incidence range among patients in 4 CML studies and 1 GIST study.

Getting answers to your questions about Gleevec

If patients have any questions about the new tablets or would like more information about Gleevec, they can call the Gleevec Hotline at 1-877-GLEEVEC (1-877-453-3832).

Source: Novartis